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. 2003 Jan 20;2003(1):CD002278. doi: 10.1002/14651858.CD002278

Buhe 1984.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 18% drop out after 3 years (study duration = 3 years). No differential group losses.
Participants 1286 children analysed at 3 years (available at final examination).
 Age range at start: 11‐13 years
 (average = 12).
 Surfaces affected at start: 17.4 DMFS.
 Background exposure to fluoride: data not obtained for fluoridation status of site.
 Year study began: 1976.
 Location: FRG.
Interventions FT (2 groups) versus PL 
 (SMFP groups = 1000 ppm F and 1500 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: IMP.
Outcomes 3yNetDFS increment ‐ cl+xr.
 Reported at 3 years follow up.
DMFS.
 DMFS (U).
 DMFT.
Notes Participants randomised (N = 1562).
 Baseline characteristics (age, TAR, DMFS) 'balanced' (DFS baseline data NR).
 Clinical (VT) caries assessment; diagnostic threshold NR; state of tooth eruption included E/U. Radiographic caries assessment; diagnostic threshold NR.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure